RA/QA Manager – STAAR China

OBJECTIVE AND MAIN TASK OF THE FUNCTION

1.    Manage aspects of complaint handling team activities (including complaint handling and vigilance activities)
2.    Act as STAAR China liaison with regulatory agencies including the NMPA and other governmental agencies, with respect to communications related to complaints, adverse events, and external audits/inspections. 
3.    Ensure compliance to Global Quality System requirements, including but not limited to Training, Documentation, CAPA and NC handling, Risk Management, Field Action and Supplier Management and qualification
4.    Support Global Regulatory Affairs team in preparing, reviewing, and maintaining medical device submissions to China NMPA
5.    Monitor changes in Chinese regulations, NMPA guidance, GB/YY standards, and related requirements
6.    Ensure timely submittal of adverse events to the NMPA.
 

TASKS

    Quality Responsibilities:

1.    Manage aspects of complaint handling team activities to ensure that the process is compliant with applicable regulations and other regulations and guidelines, as well as Company quality system requirements.
2.    Ensure that Complaint Handling SOPs appropriately reflect these regulations and requirements and that complaint handling personnel are adequately trained in procedures relevant to their activities. 
3.    Act as STAAR China liaison with regulatory agencies including the NMPA and other governmental agencies, with respect to communications related to complaints, adverse events, and external audits/inspections. 
4.    Provide complaint data and analysis to the Post-Market Surveillance system as per procedures.
5.    Ensure timely submittal of adverse events to the NMPA.
6.    Communicate with local distributors on complaints and product returns status.
7.    Coordinate complaint investigations with the Global Complaint Handling team.
8.    Maintain and monitor China complaint data.
9.    Ensure compliance to Global Quality System requirements, including but not limited to Training, Documentation, CAPA and NC Handling, Risk Management, Field Action and Supplier Management and Qualification.
10.    Provide support for Legal, Regulatory Affairs, and Medical Affairs activities, as requested.
11.    Serve as local recall coordinator
12.    Provide training, leadership, and ongoing guidance to direct report, fostering professional growth and ensuring alignment with organizational objectives and regulatory compliance
13.    Performs additional duties as assigned

Regulatory Responsibilities:

1.    Support Global Regulatory Affairs team in preparing, reviewing, and maintaining medical device submissions to China NMPA.
2.    Monitor changes in Chinese regulations, NMPA guidance, GB/YY standards, and related requirements; proactively notify the Global RA team of new or revised standards and regulatory expectations.
3.    Assess impact of new or revised Chinese standards on existing and new products and coordinate gap assessments with Global Regulatory as needed.
4.    Ensure product labeling, DFU, and packaging materials comply with NMPA and relevant Chinese standards.
5.    Coordinate labeling implementation and updates by working closely with local distributors and internal stakeholders.
6.    Assist with communications with NMPA, testing laboratories, and other regulatory bodies as required.
7.    Arrange for translations and review translated documents/labeling for regulatory accuracy and consistency with approved content.
8.    Provide regulatory review and assure compliance of promotional materials in accordance with approved labeling and applicable NMPA regulations.
9.    Performs additional duties as assigned.

REQUIREMENTS AND SKILLS

Education:    Bachelor degree in sciences or engineering, or equivalent combination of education/experience.

Special Knowledge:    

• Comprehensive knowledge of China medical device regulations and NMPA requirements, including complaint handling, adverse event reporting, vigilance systems, and post-market surveillance obligations 
• Ability to work well independently and with others.
• Excellent organizational skills and attention to detail.
• Ability to handle multiple projects simultaneously and maintain flexibility.
• In-depth knowledge and application of medical device regulations.
• Critical thinking skills and ability to follow-through.
• Excellent written and oral communication, and technical writing and editing skills.
• Good negotiation skills. 
• Working knowledge of PC-based word processing, spreadsheet, and relational database software required
• Fluent in English (spoken and written) 
• Experience working within international companies and multicultural environments

Personality:    Strong sense of responsibility, high attention to detail, and a proactive, solution-oriented mindset with effective communication and leadership abilities.

Professional Experience:    

• Minimum of 5 years of hands-on experience in Regulatory Affairs in the medical device or pharmaceutical industry strongly preferred.
• Must have experience preparing global medical product Health Authority submissions and documentation for NMPA.
• Experience in Ophthalmology or Optometry with experience in intraocular lens or vision care industry is preferred.
• Experience interacting with domestic and international healthcare professionals and company management preferred.